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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Brenner Brothers & Sons 4/3/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
(2012-DET-10)

April 03, 2012


VIA UPS


Ross K. Brenner, Partner
Burton D. Brenner, Partner
Brenner Brothers & Sons
2538 132nd Avenue
Hopkins, Michigan 49238


Messrs. Brenner:


On February 1, 13, and 17, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2538 132nd Avenue, Hopkins, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.


We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360(b). Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.


Specifically, our investigation revealed that on or about June 9, 2011 you sold a cow identified with ear tag number (b)(4) and back tag (b)(4) for slaughter as food. On or about June 10, 2011, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of liver tissue collected from this animal identified the presence of sulfadimethoxine at a level of 0.119 parts per million (ppm). FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the liver tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). The presence of this drug in the edible tissue of this animal in this amount causes the food to be adulterated under section 402(a) (2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).


Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).


We also found that you adulterated the new animal drug Di-Methox Injection ANADA 200-038 (sulfadimethoxine). Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).


The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.


Our investigation found that you administered sulfadimethoxine to an animal with ear tag number (b)(4) without following the dose as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle, in violation of 21 C.F.R. 530.41(a)(9) and your extra-label use of sulfadimethoxine resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a) and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.


You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.


You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.


Your written response should be sent to Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.


Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office